HeartBeam's Synthesized 12-lead Electrocardiogram Meets Clinical Endpoints In VALID-ECG Pivotal Study

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HeartBeam, Inc.

BEAT

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Milestone results formed the basis of HeartBeam's 12-lead ECG synthesis software application submitted to FDA in January 2025

HeartBeam, Inc., (NASDAQ:BEAT), a medical technology company focused on transforming cardiac care by providing powerful personalized insights, today announced that its groundbreaking synthesized 12-lead electrocardiogram (ECG) successfully met the clinical endpoints in the VALID-ECG pivotal study. Thomas Deering, M.D., of Piedmont Heart Institute, presented the data during the just concluded Heart Rhythm Society's annual conference in San Diego.

The study evaluated the mean difference in ECG intervals and amplitudes between HeartBeam's synthesized 12-lead ECG and simultaneously collected standard 12-lead ECG that are important in assessing non-life-threatening arrhythmias. Data showed a 93.4% overall diagnostic agreement, indicating that HeartBeam's synthesized 12-lead ECG can support diagnosis of arrhythmias in a manner consistent with standard 12-lead ECGs.

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